Biogen Inc (BIIB) 2025 Q2 法說會逐字稿

Good morning. My name is Cynthia, and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen second quarter 2025 earnings call and business update. (Operator Instructions). Today's conference is being recorded. Thank you.

早安.我叫辛西婭，今天我將擔任您的會議接線生。現在，我歡迎大家參加 Biogen 2025 年第二季財報電話會議和業務更新。（操作員指令）。今天的會議正在錄製中。謝謝。

I would now like to turn the conference over to Mr. Tim Power, Head of Investor Relations. Mr. Power, you may begin your conference.

現在，我想將會議交給投資者關係主管 Tim Power 先生。鮑爾先生，您可以開始您的會議了。

Thanks, Cynthia, and good morning, everyone. Welcome to Biogen's second quarter 2025 earnings call. During this call, we will make forward-looking statements, which involves risks and uncertainties that may cause actual results to differ materially from our forward-looking statements. We provide a comprehensive list of risk factors in our SEC filings, which I encourage you to review. Our earnings release and other documents related to our results as well as reconciliations between GAAP and non-GAAP results discussed on this call can be found on the Investors section of biogen.com. We've also posted the slide store website that we'll use during the call.

謝謝，辛西婭，大家早安。歡迎參加 Biogen 2025 年第二季財報電話會議。在本次電話會議中，我們將做出前瞻性陳述，其中涉及風險和不確定性，可能導致實際結果與我們的前瞻性陳述有重大差異。我們在提交給美國證券交易委員會的文件中提供了一份全面的風險因素清單，我鼓勵您仔細閱讀。我們的收益報告、與績效相關的其他文件，以及本次電話會議中討論的 GAAP 和非 GAAP 業績對帳表，均可在 biogen.com 的「投資者」板塊找到。我們也發布了電話會議期間將使用的幻燈片商店網站。

On today's call, I'm joined by our President and Chief Executive Officer, Chris Viehbacher; Dr. Priya Singhal, Head of Development; Alisha Alaimo, our President and Head of North America; and Robin Kramer, our Chief Financial Officer. We'll make some opening comments and then move to Q&A. And to allow us to get through as many questions as possible, we kindly ask that you limit yourself to just one question.

在今天的電話會議上，與我一起參加會議的還有我們的總裁兼執行長 Chris Viehbacher、開發主管 Priya Singhal 博士、我們的總裁兼北美主管 Alisha Alaimo 以及我們的財務長 Robin Kramer。我們將發表一些開場白，然後進入問答環節。為了讓我們能夠解答盡可能多的問題，我們懇請您將問題限制在一個範圍內。

I'll now turn the call over to Chris.

我現在將電話轉給克里斯。

Thank you, Tim. Good morning, everybody. We're very pleased with the performance in the second quarter. In particular, we've seen the growth from our new product launches offsetting our MS decline. MS has also proven to be a little bit more resilient this quarter. There was some gross to net adjustment.

謝謝你，提姆。大家早安。我們對第二季的表現非常滿意。特別是，我們看到新產品的推出帶來的成長抵消了 MS 的下降。本季度，微軟也展現了更強的韌性。存在一些總額與淨額的調整。

But I would like to call out the performance of VUMERITY. I think Alisha and her team in the US, in particular, have put a lot of emphasis on VUMERITY over the last two years, and we've been seeing some nice growth. And this is a product where we still got a lot of market exclusivity into the future.

但我想讚揚一下 VUMERITY 的表現。我認為 Alisha 和她在美國團隊尤其在過去兩年中非常重視 VUMERITY，我們已經看到了一些不錯的成長。這是我們未來仍擁有大量市場獨佔權的產品。

As we look at the growth products, I think we're also seeing continued consistent growth with LEQEMBI. We've got a number of enablers coming along that hopefully will remove some of the bottlenecks in the system. Those are things like the blood-based biomarkers. The first one has now been approved, but there are now multiple biomarker tests out there. We have a PDUFA date for our subcutaneous formulation for maintenance coming at the end of August.

當我們觀察成長產品時，我認為我們也看到 LEQEMBI 持續穩定成長。我們已採取多項措施，希望能夠消除系統中的一些瓶頸。這些都是類似血液中的生物標記。第一項測試現已獲得批准，但目前已有多個生物標記測試可供選擇。我們的皮下維持治療製劑的 PDUFA 日期是 8 月底。

And I think those are all things that are starting to generate some potential shift in momentum in LEQEMBI, but Alisha will talk about that more. But I'd say, I think we're feeling pretty encouraged by what we're seeing there.

我認為這些都是開始在 LEQEMBI 中產生一些潛在轉變的因素，但 Alisha 會更多地談論這一點。但我想說，我認為我們對在那裡看到的情況感到非常鼓舞。

SKYCLARYS, again, now is available in 29 markets. We have probably as many, if not more, patients outside the US as inside the US. It's rolling out extremely well. Not all patients are on reimbursed yet. And I think as we progress each country, we've been able to get a lot of patients on early access programs. What we have seen is extremely strong take-up in those programs, and then we work basically country by country to get reimbursement.

SKYCLARYS 現已在 29 個市場上市。我們在美國境外的患者數量可能與美國境內的患者數量一樣多，甚至更多。它的進展非常順利。並非所有患者都已獲得報銷。我認為，隨著每個國家的進步，我們已經能夠讓許多患者參與早期獲取計畫。我們看到這些項目的接受度非常高，然後我們基本上逐一開展工作以獲得報銷。

ZURZUVAE has had an extremely nice quarter. And again, I think Alisha will be able to give some more color commentary. But I think that's a bit of a sleeper in our portfolio. I think is certainly outperforming our internal expectations. We also had good news in the quarter. We got approval in Europe, and we're looking forward to planning the launch there.

ZURZUVAE 本季表現非常好。再次，我認為 Alisha 能夠給出更多精彩的評論。但我認為這對我們的投資組合來說有點不重要。我認為肯定超出了我們的內部預期。本季我們也傳來了好消息。我們已獲得歐洲的批准，並期待在那裡推出該產品。

As we turn to the pipeline, Priya is going to obviously be able to say more, but we've had some very good news there. All Phase III studies for felzartamab have been initiated. We potentially have another study being started in microvascular inflammation that could add to that portfolio. We saw some really interesting results for salanersen. This is our next-generation product for SMA, and we're quite excited about that, and that will be another Phase III that starts this year.

當我們談到管道時，普里亞顯然能夠說更多，但我們已經得到了一些非常好的消息。Felzartamab 的所有 III 期研究均已啟動。我們可能正在進行另一項有關微血管發炎的研究，這可能會豐富我們的研究範圍。我們看到了一些有關 salanersen 的非常有趣的結果。這是我們針對 SMA 的下一代產品，我們對此感到非常興奮，這將是今年開始的另一個第三階段。

On business development, we continue to look across the spectrum of our development pipeline. We're very excited about the research agreement that we concluded in the past quarter with City Therapeutics. And we would expect to see several more of those research collaborations this year. We continue to look at later stage, both M&A and collaborations. But again, we remain disciplined in terms of ensuring that anything we do would drive shareholder value.

在業務發展方面，我們持續專注於整個發展管道。我們對上個季度與 City Therapeutics 達成的研究協議感到非常興奮。我們預計今年將看到更多這樣的研究合作。我們繼續關注後期，包括併購和合作。但同樣，我們仍將嚴格遵守紀律，確保我們所做的一切都能為股東創造價值。

So I think if I look at the quarter, we've got growth top and bottom line. We've had very strong discipline on costs. And so I think the company is performing well.

因此我認為，如果我看一下本季度，我們的營收和利潤都會有所成長。我們對成本有著非常嚴格的控制。所以我認為公司表現良好。

And with that, I'll turn it over to Priya who can give us a lot more detail about the pipeline.

接下來，我將把時間交給 Priya，她可以向我們提供有關管道的更多細節。

Thank you, Chris. This quarter, we made significant progress in continuing to build the breadth and depth across the pipeline in key areas. We obtained a positive CHMP opinion for zuranolone in Europe, initiated three Phase III studies, the pediatric Phase III study for SKYCLARYS as well as felzartamab Phase III studies for IgAn and PMN. And we are working with Stroke Therapeutics towards an imminent [FPI] for zorevunersen. We're also working to further expand felzartamab into a fourth indication called late microvascular inflammation, or MVI, in patients who have had a kidney transplant.

謝謝你，克里斯。本季度，我們在繼續擴大關鍵領域管道的廣度和深度方面取得了重大進展。我們獲得了歐洲 CHMP 對 zuranolone 的積極評價，並啟動了三項 III 期研究，即 SKYCLARYS 的兒科 III 期研究以及針對 IgAn 和 PMN 的 felzartamab III 期研究。我們正在與 Stroke Therapeutics 合作，即將為 zorevunersen 進行 [FPI]。我們也致力於進一步擴展 felzartamab 的第四種適應症，即晚期微血管發炎（MVI），適用於接受過腎臟移植的患者。

In support of our continued scientific leadership, we have also presented new data across our key franchises at medical congresses, including Cure SMA, EPNS, EULAR, and Lupus 2025. And just yesterday at AAIC, new long-term data on LEQEMBI, showing treatment benefits over four years with the continued use and bioequivalence data for the initiation dose of subcutaneous lecanemab was presented.

為了支持我們繼續保持科學領導地位，我們也在醫學會議上展示了我們主要特許經營權的新數據，包括 Cure SMA、EPNS、EULAR 和 Lupus 2025。就在昨天的 AAIC 上，LEQEMBI 的新長期數據顯示，持續使用四年可帶來治療益處，並且皮下注射 lecanemab 的起始劑量具有生物等效性數據。

This quarter, we also announced exciting new interim Phase Ib data for salanersen in SMA, as Chris mentioned, demonstrating proof of concept. As the company that led transformation in SMA, we are excited about the potential to continue that journey and potentially address the residual unmet needs for patients. salanersen leverages the same mechanism of action at SPINRAZA, but was designed to be a more potent molecule and hence, enable the potential for high efficacy with once-yearly dosing, a profile we believe that can further address the needs of the SMA community.

正如克里斯所提到的，本季度我們還公佈了薩拉納森在 SMA 治療中的令人興奮的全新中期 Ib 期數據，證明了概念的有效性。作為引領 SMA 變革的公司，我們對繼續這趟旅程並可能解決患者剩餘未滿足需求的潛力感到興奮。 salanersen 利用與 SPINRAZA 相同的作用機制，但旨在成為一種更有效的分子，因此，透過每年一次的給藥即可實現高性能，我們相信這可以進一步滿足 SMA 群體的需求。

The Phase Ib study included children who had previously been treated with gene therapy, but had not achieved the expected motor milestones based on their age, such as sitting, standing, or walking despite the extended period of time since having received the gene therapy. We presented the interim results of this study at the pure SMA meeting last month. and I would like to review the key features of that data with you next.

Ib 期研究的參與者是先前接受過基因治療的兒童，儘管接受基因治療已經很長時間了，但仍然沒有達到根據年齡預期的運動里程碑，例如坐、站或走。我們在上個月的純 SMA 會議上展示了這項研究的中期結果。接下來我想和大家一起回顧這些數據的主要特徵。

While this is a small data set, several features are compelling. First, salanersen was evaluated as a once-a-year administration. Second, we are seeing a significant reduction in neurofilament, which as you know, is a marker neurodegeneration. And third, we observed meaningful improvements in motor function, including achievement of significant motor milestones.

雖然這是一個很小的資料集，但其中有幾個特徵引人注目。首先，薩拉納森被評估為一年一次的給藥方式。其次，我們發現神經絲明顯減少，眾所周知，這是神經退化性疾病的標誌。第三，我們觀察到運動功能的顯著改善，包括實現重要的運動里程碑。

And on the right-hand side of this slide, you can see two examples of participants who were previously treated with gene therapy several years prior to receiving salanersen. The first row represents a child who received gene therapy at around one year of age and could not sit when they enrolled in this trial at approximately five years of age. They received salanersen 80 milligrams, one dose, and by their 90-day visit, they were able to sit independently.

在這張投影片的右側，您可以看到兩位參與者的例子，他們在接受 salanersen 治療前幾年曾接受過基因治療。第一行代表一個孩子，他在一歲左右時接受了基因治療，大約五歲時參加這次試驗時還不能坐。他們接受了一次劑量的薩拉納森 (80 毫克)，在 90 天的就診期間，他們已經能夠獨立坐著。

Naturally, these results need to be confirmed in a registrational trial. But these types of data support the potential of salanersen to transform the standard of care in SMA. And we're working with urgency as we engage with global regulators and finalize the Phase III study design.

當然，這些結果需要在註冊試驗中得到證實。但這些類型的數據支持了薩拉納森改變 SMA 治療標準的潛力。我們正在緊急與全球監管機構合作，最終確定第三階段研究的設計。

Turning to the lupus pipeline. Together with UCB, we were excited to present new data from the positive Phase III dapi study in SLE. We know from patients that fatigue is a very common symptom in lupus. It affects up to 90% of patients and is often described as the most disabling symptoms of the disease. It can present as a profound, persistent, and debilitating tiredness and has proven to be a difficult-to-treat symptom of lupus.

轉向狼瘡管道。我們很高興與 UCB 一起展示 SLE 中積極的 III 期 dapi 研究的新數據。我們從患者那裡了解到，疲勞是狼瘡的一個非常常見的症狀。它影響多達 90% 的患者，並常被描述為該疾病最嚴重的症狀。它可能表現為嚴重、持續且使人衰弱的疲勞，並且已被證明是一種難以治療的狼瘡症狀。

What's important about this new analysis that we presented at EULAR is that dapi demonstrated consistent improvements across multiple domains of fatigue beyond what was achieved with just standard of care alone. This includes the newly developed FATIGUE-PRO, which is a novel fatigue measure in patients with SLE. These results further reinforce the potential for dapi to address the unmet need and become an important new treatment for SLE.

我們在 EULAR 上展示的這項新分析的重要之處在於，dapi 在疲勞的多個領域表現出了持續的改善，遠遠超出了僅透過標準護理所取得的改善。其中包括新開發的 FATIGUE-PRO，這是 SLE 患者的一種新型疲勞測量方法。這些結果進一步證明了 dapi 滿足未滿足需求並成為 SLE 重要新療法的潛力。

Reflecting on our achievements this quarter, I believe that we're making steady progress towards our goal of transforming the pipeline and delivering the new Biogen. The next 12 to 18 months are marked by multiple key expected scientific milestones and regulatory outcomes, including LEQEMBI subcutaneous maintenance and high dose SPINRAZA.

回顧本季的成就，我相信我們正在朝著轉變管道和交付新 Biogen 的目標穩步前進。未來 12 至 18 個月將迎來多個關鍵的科學里程碑和監管成果，包括 LEQEMBI 皮下維持治療和高劑量 SPINRAZA。

And given the central role of the pipeline for our long-term growth strategy, we plan to build upon last quarter's felzartamab Investor Webcast by hosting a second thematic seminar this fall, now focused on our lupus pipeline.

鑑於該管道在我們的長期成長策略中發揮的核心作用，我們計劃在上個季度的 felzartamab 投資者網路廣播的基礎上，在今年秋季舉辦第二次專題研討會，重點關注我們的狼瘡管道。

With that, I would like to now hand the call over to Alisha for an update on our commercial business. Thank you.

說完這些，我現在想把電話交給 Alisha，讓她介紹一下我們的商業業務的最新情況。謝謝。

Thank you, Priya, and good morning, everyone. Today, I'll review the strong commercial execution we delivered in Q2 and how evolving market dynamics have created new opportunities that drove our most recent growth. As many of you may remember, more than 18 months ago, we reallocated capital as part of our Fit-for-Growth initiative to prepare for four new launches in the US market. We took a hard look at our investments in MS to determine where they deliver the strongest return. And today, we believe we're seeing the results of those decisions.

謝謝你，普里婭，大家早安。今天，我將回顧我們在第二季度實現的強勁商業執行情況，以及不斷變化的市場動態如何創造新的機會來推動我們最近的成長。你們很多人可能還記得，18 個多月前，作為「適合成長」計畫的一部分，我們重新分配了資本，為在美國市場推出四款新產品做準備。我們仔細審查了對 MS 的投資，以確定哪些投資能帶來最強勁的回報。今天，我們相信我們已經看到了這些決定的成果。

Before turning to the launch products, let me remind you that our MS business has remained resilient and an important contributor to our cash flow. Looking at Q2 performance, in addition to some onetime items benefiting the quarter, I am encouraged by the strength of VUMERITY as it continued to grow. We believe these results demonstrate the value of our team's deep institutional knowledge, strong access and relationships in immunology.

在介紹推出的產品之前，我想提醒大家，我們的 MS 業務一直保持著彈性，並且是我們現金流的重要貢獻者。縱觀第二季的表現，除了一些對本季有利的一次性專案外，VUMERITY 的持續成長實力也令我感到鼓舞。我們相信這些結果證明了我們團隊在免疫學領域的深厚機構知識、強大的管道和關係的價值。

Moving on to SKYCLARYS. We are delivering on our commitment to bring the first Friedreich Ataxia treatment to patients around the world. SKYCLARYS is now available in 29 markets globally, including key European countries and Brazil. Expanding into new markets is helping us realize the full potential of SKYCLARYS, and we grew revenue 5% globally compared to last quarter.

繼續討論 SKYCLARYS。我們正在履行承諾，為世界各地的患者提供首個弗里德賴希共濟失調治療方法。SKYCLARYS 目前已在全球 29 個市場上市，包括歐洲主要國家和巴西。拓展新市場有助於我們充分發揮 SKYCLARYS 的潛力，與上一季相比，我們全球營收成長了 5%。

Last year at this time, I shared the deliberate pivot made by our US rare disease team to redirect investments to reach the remaining patients treated in the community as opposed to our initial patients who were primarily at centers of excellence. We learned patients in the community had a different profile. They are generally older, averaging older than 40 years old, and often with slower progressing forms of FA. Now keep in mind, community neurologists and primary care providers may only treat one or two FA patients in their career, so they can require more education.

去年此時，我分享了我們美國罕見疾病團隊所做的刻意轉變，即將投資轉向為社區中接受治療的剩餘患者提供治療，而不是主要在卓越中心接受治療的初始患者提供治療。我們了解到社區中的患者有不同的情況。他們一般年齡較大，平均年齡超過 40 歲，且 FA 的進展通常較慢。現在請記住，社區神經科醫生和初級保健提供者在其職業生涯中可能只會治療一兩名 FA 患者，因此他們可能需要接受更多的教育。

We have deployed advanced rare disease capabilities to identify patients in need and help HCPs understand the progressive nature of the disease and the potential urgency to start treatment on SKYCLARYS. I believe this shift in focus was a key factor behind the 13% quarter-over-quarter revenue growth in the US. And in Q2, approximately 70% of new start forms were written by the community neurologists and PCPs. This reinforces our belief in our ability to reach the remaining patient population in need.

我們部署了先進的罕見疾病治療能力，以識別有需要的患者，並幫助 HCP 了解疾病的進展性質以及開始使用 SKYCLARYS 治療的潛在緊迫性。我認為這種關注點的轉變是美國季度營收季增 13% 的關鍵因素。在第二季度，大約 70% 的新開始表格是由社區神經科醫生和 PCP 撰寫的。這增強了我們對於能夠幫助剩餘有需要的患者群體的信心。

As we have noted before, while we anticipate continued growth in the US. the pace may fluctuate from quarter to quarter due to the time it can take to identify and reach potential patients.

正如我們之前所指出的，雖然我們預計美國將繼續成長，但由於識別和接觸潛在患者需要時間，因此成長速度可能每季都會有所波動。

We remain optimistic about the global opportunity, and we're encouraged that new clinical guidelines from the leading patient advocacy group and KMEs across the world are recommending intervention with SKYCLARYS. We believe this is helping to build momentum and prescriber awareness for the only DMT to slow the progression of FA.

我們對全球機會保持樂觀，我們很高興看到來自世界各地領先的患者權益組織和 KME 的新臨床指南建議使用 SKYCLARYS 進行幹預。我們相信，這有助於為唯一能夠減緩 FA 進展的 DMT 建立動力並提高處方者的認識。

Next, turning to ZURZUVAE. We delivered 68% quarter-over-quarter revenue growth in the US, supported by a 29% increase in new prescribers. Earlier this year, we expanded our field team, and in just a few months, their impact is reinforcing our belief in ZURZUVAE's potential for sustained growth. Repeat prescribers now account for nearly 70% of scripts, which we believe indicates HCP's growing trust and willingness to treat PPD with ZURZUVAE. And last quarter, 80% of ZURZUVAE prescriptions were written as first-line therapy.

接下來，轉向 ZURZUVAE。我們在美國實現了 68% 的季度環比收入成長，這得益於新處方數量增加了 29%。今年早些時候，我們擴大了現場團隊，在短短幾個月內，他們的影響力就增強了我們對 ZURZUVAE 持續成長潛力的信心。目前重複開處方者佔處方總數的近 70%，我們認為這表明 HCP 對使用 ZURZUVAE 治療 PPD 的信任度和意願日益增強。上個季度，80% 的 ZURZUVAE 處方都是作為第一線療法開出的。

Today, most reimbursement policies do not require step edits or complex prior authorizations, helping to accelerate patient access. Looking ahead, we are hopeful to bring ZURZUVAE to patients outside the United States.

如今，大多數報銷政策不需要逐步編輯或複雜的事先授權，有助於加快病患就醫速度。展望未來，我們希望將 ZURZUVAE 帶給美國以外的患者。

And lastly, shifting to LEQEMBI. The US Alzheimer's market is undergoing a significant evolution that began with LEQEMBI's FDA approval just two years ago. To accelerate this large-scale change, our efforts at launch were primarily focused on helping health systems establish capabilities to diagnose, treat, and safely monitor a high volume of Alzheimer's patients. We believe sites are making progress.

最後，轉向 LEQEMBI。美國阿茲海默症市場正在經歷重大變革，這項變革始於兩年前 LEQEMBI 獲得 FDA 批准。為了加速這一大規模變革，我們在啟動時的努力主要集中在幫助衛生系統建立診斷、治療和安全監測大量阿茲海默症患者的能力。我們相信網站正在取得進步。

For example, we estimate that since the beginning of LEQEMBI's launch, nearly one-third of customers have begun diagnosing MCI and mild AD patients for the very first time. On average, Medicare claims data has shown that prescribers have reduced the time from diagnosis to first infusion by six weeks since the beginning of last year.

例如，我們估計自 LEQEMBI 推出以來，近三分之一的客戶首次開始診斷 MCI 和輕度 AD 患者。平均而言，醫療保險索賠數據顯示，自去年年初以來，處方人員將從診斷到首次輸液的時間縮短了六週。

This year, we also see significant improvements in the time it takes sites to add patients beyond their first one and in their depth of prescribing. Monthly PET testing has increased approximately fivefold over the last 1.5 years. Blood-based biomarker testing has grown by 50% in the past six months from two of the major lab companies and has nearly tripled in the past year. We think this is an early promising indication that there is high awareness and willingness to adopt blood-based biomarkers. We will work in partnership with the Alzheimer's community to educate about the quality of these tests and explore the opportunity for widespread use.

今年，我們也看到，各醫療機構在增加第一位患者之後所需的時間以及處方深度都有了顯著改善。在過去 1.5 年裡，每月的 PET 檢測數量增加了約 5 倍。在過去六個月中，兩家大型實驗室公司的血液生物標記檢測增加了 50%，過去一年中增加了近兩倍。我們認為這是一個早期的有希望的跡象，表明人們對採用基於血液的生物標誌物有很高的認識和意願。我們將與阿茲海默症社群合作，宣傳這些測試的品質並探索廣泛使用的機會。

This maturing of the market infrastructure gave us confidence earlier this year to launch new initiatives with ASI, including sharper messaging, a targeted brand campaign, and a more precise focus on physicians with the highest potential to prescribe, and we believe these are driving momentum. In Q2, US revenue grew 20% quarter over quarter, and we increased new LEQEMBI prescribers 34% year to date. It is particularly encouraging to see (technical difficulty) that we believe the anti-amyloid market is now growing approximately 15% in Q2. These dynamics are prompting us to deploy the next phase of initiatives designed to further increase LEQEMBI prescribing.

市場基礎設施的成熟使我們在今年稍早有信心與 ASI 一起推出新舉措，包括更清晰的訊息傳遞、有針對性的品牌活動，以及更精準地關注最有潛力開處方的醫生，我們相信這些正在推動發展勢頭。第二季度，美國營收季增 20%，今年迄今，新的 LEQEMBI 處方數量增加了 34%。尤其令人鼓舞的是（技術難度），我們相信抗澱粉樣蛋白市場在第二季成長了約 15%。這些動態促使我們部署下一階段的舉措，旨在進一步增加 LEQEMBI 處方。

Today, awareness about Alzheimer's disease is high. Unfortunately, patient and caregiver awareness of new treatments is low. However, our research shows that when patients ask about LEQEMBI and HCP will prescribe it most of the time. With health systems having advanced their capabilities to treat, we activated our direct-to-consumer campaign across TV and digital platforms to build patient demand and awareness. In our campaign testing, patients and caregivers felt empowered to pursue treatments and earlier intervention if LEQEMBI can help them still be like themselves longer.

如今，人們對阿茲海默症的認知已經很高。不幸的是，患者和照護者對新療法的認知程度較低。然而，我們的研究表明，當患者詢問 LEQEMBI 時，HCP 大多數情況下都會開出這種藥物。隨著醫療系統治療能力的提高，我們在電視和數位平台上啟動了直接面向消費者的活動，以建立患者的需求和意識。在我們的活動測試中，如果 LEQEMBI 可以幫助患者和照護者更長時間地保持自我狀態，他們就會感到有能力去尋求治療和早期介入。

In parallel, we plan to pilot later this year an expanded field team to understand how to improve PCP referrals in key geographies. We are also preparing for the potential subcutaneous formulations of LEQEMBI, which we believe would add convenience and optionality for patients, caregivers, and HCPs. Looking ahead, we believe that our disciplined execution, efficient investments, and our ability to adapt to evolving market dynamics positions us to sustain this momentum and deliver continued growth.

同時，我們計劃在今年稍後試行一個擴大的現場團隊，以了解如何改善主要地區的 PCP 轉診。我們也正在為 LEQEMBI 的潛在皮下製劑做準備，我們相信這將為患者、照護者和 HCP 增加便利性和可選性。展望未來，我們相信，我們嚴謹的執行、高效的投資以及適應不斷變化的市場動態的能力使我們能夠保持這一勢頭並實現持續成長。

I will now turn it over to Robin for an update on our financial results.

現在我將把時間交給羅賓來更新我們的財務表現。

Thank you, Alisha. I'd like to provide some key highlights from our strong second-quarter financial results. Unless otherwise noted, each of the comparisons I make during my remarks are versus the second quarter of 2024. We delivered 7% revenue growth in the quarter on strong commercial execution, particularly from our four launch products, which generated $252 million in revenue in the quarter and our MS business in the US. This strong commercial execution, combined with our disciplined operating expense management, resulted in non-GAAP diluted EPS growth of 4% in the quarter. Absent the approximately $0.26 impact from the acquired IPR&D upfront and milestone expense in the quarter, non-GAAP diluted EPS would have been $5.73, up 9%.

謝謝你，艾莉莎。我想提供一些我們第二季強勁財務業績的關鍵亮點。除非另有說明，我在發言中所做的每個比較都是與 2024 年第二季進行比較。由於強勁的商業執行，我們本季實現了 7% 的營收成長，尤其是我們的四款上市產品（本季度創造了 2.52 億美元的收入）以及我們在美國 MS 業務。強勁的商業執行力，加上我們嚴格的營運費用管理，使得本季非公認會計準則稀釋每股收益成長 4%。如果不考慮本季收購的 IPR&D 前期費用和里程碑費用約 0.26 美元的影響，非 GAAP 稀釋每股收益將為 5.73 美元，成長 9%。

Based on the strength of the business performance in the first half of the year, we are raising our full year 2025 financial guidance. I will provide details on guidance shortly. First, I will cover our Q2 performance.

基於上半年業務表現的強勁，我們上調了 2025 年全年財務預期。我將很快提供有關指導的詳細資訊。首先，我將介紹我們第二季的業績。

Starting with our MS franchise. In the US, as Alisha noted, we had a strong quarter with revenue of $657 million. This was driven in part by higher VUMERITY demand, approximately $32 million of favorable inventory dynamics from (technical difficulty) and TYSABRI and an approximately $48 million favorable gross to net change in estimate impact across the franchise with $27 million of this gross to net dynamic favorably impacting VUMERITY.

從我們的 MS 特許經營開始。正如 Alisha 所說，在美國，我們本季表現強勁，營收達到 6.57 億美元。部分原因是 VUMERITY 需求增加、（技術難度）和 TYSABRI 帶來的約 3200 萬美元的有利庫存動態以及整個特許經營權估計影響中約 4800 萬美元的有利毛利對淨利變化，其中 2700 萬美元的毛利對淨利動態對 VUMERITY 產生了有利影響。

Outside the US, sales are primarily impacted by expected generic pressures for TECFIDERA and a biosimilar for TYSABRI in Europe. We continue to defend our IP. However, we expect accelerating competitive pressures on the ex-US MS business in the second half of 2025, particularly for TECFIDERA in Europe.

在美國以外，銷售額主要受到歐洲 TECFIDERA 仿製藥和 TYSABRI 生物相似藥預期壓力的影響。我們將繼續捍衛我們的智慧財產權。然而，我們預計 2025 年下半年美國以外的 MS 業務將面臨加速的競爭壓力，尤其是歐洲的 TECFIDERA。

For SPINRAZA, we continue to be encouraged by the consistency in demand globally. And as expected, ex US SPINRAZA was impacted by the drawdown of the inventory build from the first quarter, which we expect to continue into Q3. We continue to expect full-year global SPINRAZA revenue to be relatively similar in 2025 as compared to 2024. Due to timing of shipments, we expect revenue in the second half of the year to be lower than the first half.

對 SPINRAZA 而言，全球需求的持續穩定令我們感到鼓舞。正如預期的那樣，除美國以外，SPINRAZA 受到第一季庫存減少的影響，我們預計這種影響將持續到第三季。我們仍然預計 2025 年 SPINRAZA 全年全球收入將與 2024 年基本持平。由於出貨時間的原因，我們預計下半年的收入將低於上半年。

Our four launch products each saw increases in demand in the second quarter and together delivered $252 million of revenue to Biogen, which was an increase of 26% quarter over quarter and 91% year over year. Again, this quarter, the year-over-year performance of these products together offset the decline in our MS portfolio. We continued to see steady sequential demand growth for LEQEMBI globally with second quarter global end market sales booked by ASI of approximately $160 million.

我們推出的四款產品在第二季度的需求均有所增長，共為 Biogen 帶來了 2.52 億美元的收入，環比增長 26%，同比增長 91%。同樣，本季度，這些產品的同比表現共同抵消了我們 MS 產品組合的下滑。我們持續看到全球對 LEQEMBI 的需求穩定成長，ASI 第二季全球終端市場銷售額約為 1.6 億美元。

This includes the favorable impact of the timing of shipments to China of approximately $35 million as the collaboration optimized global inventory positions in Q2. We expect this inventory build to work down in the second half of the year. What is encouraging is that excluding the China shipment timing impact, global sales grew 29% sequentially and 211% year over year.

這包括由於合作在第二季度優化了全球庫存狀況，對中國發貨時間產生的約 3500 萬美元的有利影響。我們預計庫存增加將在今年下半年下降。令人鼓舞的是，排除中國出貨時間的影響，全球銷售額較上季成長 29%，較去年同期成長 211%。

SKYCLARYS saw continued demand growth globally, and the US demand growth more than offset the expected Medicare discount dynamics in the quarter. Internationally, SKYCLARYS was negatively impacted by the timing of shipments in certain markets. We expect SKYCLARYS to continue to grow globally, and we are working to secure reimbursement in certain European markets as well as in Brazil.

SKYCLARYS 的全球需求持續成長，美國的需求成長超過了本季預期的醫療保險折扣動態。在國際上，SKYCLARYS 受到某些市場出貨時間的負面影響。我們預計 SKYCLARYS 將在全球範圍內繼續成長，並且我們正在努力確保在某些歐洲市場以及巴西獲得報銷。

We experienced strong demand growth for ZURZUVAE in the quarter. And as Alisha noted, Q2 revenue was $46 million, up 213% year over year and 68% quarter over quarter.

本季度，我們對 ZURZUVAE 的需求成長強勁。正如 Alisha 所指出的，第二季營收為 4,600 萬美元，年增 213%，環比成長 68%。

As a reminder, Biogen shares 50% of the profit or loss on ZURZUVAE, which is recognized in the collaboration profit sharing line on our P&L. I would like to note we understand that earlier this month, IQVIA updated their methodology for reporting shipped prescriptions for ZURZUVAE and other products as part of their routine data review. This may mean the capture rate may be lower.

提醒一下，Biogen 分享 ZURZUVAE 的 50% 利潤或損失，這在我們的損益表的合作利潤分享項目中確認。我想指出的是，我們了解到本月早些時候，IQVIA 作為其常規數據審查的一部分更新了報告 ZURZUVAE 和其他產品已發貨處方的方法。這可能意味著捕獲率可能會更低。

We are encouraged by the opportunity for ZURZUVAE, including the potential in Europe with the recent positive CHMP opinion.

我們對 ZURZUVAE 的機會感到鼓舞，包括最近 CHMP 的正面評價以及其在歐洲的潛力。

Turning to contract manufacturing revenue. The increase in revenue was driven by the acceleration of timing for manufacturing batch releases, some of which were associated with LEQEMBI due to our Q4 planned plant maintenance activity. We continue to believe that contract manufacturing revenue will be roughly consistent when comparing full year 2025 with full year 2024, and we expect minimal revenue in Q4 2025 due to the planned maintenance activity.

轉向合約製造收入。收入的成長是由於製造批次發佈時間的加快，其中一些與 LEQEMBI 有關，因為我們計劃在第四季度進行工廠維護活動。我們仍然相信，與 2024 年全年相比，2025 年全年的合約製造收入將大致保持一致，並且由於計劃中的維護活動，我們預計 2025 年第四季的收入將很少。

Now a few comments on the rest of the P&L. Non-GAAP cost of sales was impacted by higher lower-margin contract manufacturing revenue in Q2 2025, a continuation of the trend we saw in the first quarter as we accelerated batches ahead of the planned Q4 plant maintenance I just mentioned.

現在對損益表的其餘部分提出一些評論。非公認會計準則銷售成本受到 2025 年第二季低利潤合約製造收入增加的影響，這是我們在第一季度看到的趨勢的延續，因為我們在剛才提到的計劃中的第四季度工廠維護之前加快了批次生產。

Non-GAAP core operating expense or R&D plus SG&A expense decreased 2% year over year as we continued to deliver on our R&D prioritization and Fit-for-Growth initiatives. Non-GAAP operating income included approximately $47 million of acquired and process R&D charges. This includes $16 million related to City Therapeutics transaction and a $30 million milestone related to initiation of the second Phase III study for felzartamab. Excluding the impact from acquired IPR&D, non-GAAP operating income would have been approximately $1 billion, up 5% year over year.

由於我們繼續履行研發優先順序和適合成長的計劃，非公認會計準則核心營運費用或研發加銷售、一般及行政費用較去年同期下降 2%。非公認會計準則營業收入包括約 4,700 萬美元的收購和製程研發費用。其中包括與 City Therapeutics 交易相關的 1,600 萬美元，以及與啟動 felzartamab 第二階段 III 期研究相關的 3,000 萬美元里程碑資金。不計收購智慧財產權與研發的影響，非公認會計準則營業收入約 10 億美元，較去年同期成長 5%。

Now I'd like to provide a brief update on our balance sheet. We generated $134 million of free cash flow in the second quarter. This reflects $745 million in cash tax payments in the quarter our cash tax payments for the year are heavily concentrated in Q2. Also in the second quarter, we used the proceeds of the $1.75 billion of newly issued debt to fully redeem our $1.75 billion of senior notes that were due in September. And while this financial transaction resulted in no net change to our overall debt profile, we expect roughly $15 million to $20 million of incremental interest expense in the second half of 2025, which we have factored into our updated guidance for the year.

現在我想簡單介紹一下我們的資產負債表。我們在第二季產生了 1.34 億美元的自由現金流。這反映了本季 7.45 億美元的現金稅支付，我們全年的現金稅支付主要集中在第二季。此外，在第二季度，我們利用 17.5 億美元新發行債券的收益全額贖回了 9 月到期的 17.5 億美元優先票據。雖然這筆金融交易並未對我們的整體債務狀況造成淨變化，但我們預計 2025 年下半年的增量利息支出約為 1500 萬至 2000 萬美元，我們已將其計入年度更新指引中。

We ended the second quarter with $2.8 billion of cash and approximately $3.5 billion of net debt. And we believe that our balance sheet remains strong, allowing us to continue to invest in both internal and external growth opportunities. We believe the structure of our business model positions us to be potentially more resilient to macroeconomic factors and policy uncertainty. Today, a significant portion of our US product revenue is derived from products which are largely manufactured in the United States.

截至第二季末，我們的現金餘額為 28 億美元，淨債務約為 35 億美元。我們相信，我們的資產負債表依然強勁，使我們能夠繼續投資於內部和外部的成長機會。我們相信，我們的商業模式結構使我們能夠更好地抵禦宏觀經濟因素和政策不確定性。如今，我們美國產品收入的很大一部分來自於主要在美國製造的產品。

And we recently announced a plan to continue to invest in our North Carolina manufacturing operations. This is a combination of capital and operating expense over several years that is intended to modernize and add manufacturing capabilities to fuel the continued advancement of Biogen's late-stage pipeline and support our next wave of potential products.

我們最近宣布了一項繼續投資北卡羅來納州製造業務的計劃。這是數年資本和營運支出的組合，旨在現代化和增加製造能力，以推動 Biogen 後期管道的持續進步並支持我們的下一波潛在產品。

It is also important to note that there are other aspects of our business model that we believe are important to our ability to be resilient in an uncertain environment. We generate a relatively high percentage of our revenue outside of the US. We also have a significant Rare Disease business. And our payer channel mix in the US is diversified and skewed more towards commercial payers. We believe these are important considerations as we navigate the current environment, and we will continue to monitor the evolving landscape.

值得注意的是，我們認為我們的商業模式的其他方面對於我們在不確定的環境中保持彈性的能力也很重要。我們在美國以外地區創造了相對較高比例的收入。我們也擁有重要的罕見疾病業務。我們在美國的付款管道組合多樣化，並且更偏向商業付款人。我們相信，這些都是我們在應對當前環境時需要考慮的重要因素，我們將繼續關注不斷變化的情況。

Turning now to guidance, where we have raised our full year 2025 non-GAAP diluted earnings per share to be in the range of between $15.50 and $16 from $14.50 to $15.50. We are raising our guidance to reflect a stronger expected business outlook for the full year, largely reflecting the strong first half revenue performance including the resilient performance of the US business and MS and the performance of our launch products, partially offset by the impact of the City Therapeutics transaction in the second quarter. Please note that the impact from the $30 million felzartamab milestone I mentioned earlier was already contemplated in our previous guidance.

現在談談業績指引，我們已將2025年全年非公認會計準則每股攤薄收益從14.50美元上調至15.50美元，介於15.50美元至16美元之間。我們上調業績指引是為了反映全年更強勁的預期業務前景，這主要反映了上半年強勁的營收表現，包括美國業務和多發性硬化症（MS）的強勁表現以及我們上市產品的強勁表現，但部分抵消了第二季度City Therapeutics交易的影響。請注意，我之前提到的 3000 萬美元 felzartamab 里程碑的影響已經在我們之前的指導中考慮到了。

The following are some key considerations underlying the guidance raise. We now expect total revenue for 2025 to be approximately flat compared to full year 2024. This reflects the strong first half revenue performance, including the resilient performance of the US MS business.

以下是提高指導價的一些關鍵考慮因素。我們現在預計 2025 年的總收入將與 2024 年全年大致持平。這反映了上半年強勁的收入表現，包括美國 MS 業務的強勁表現。

Excluding the $75 million of favorability from inventory and the onetime gross-to-net adjustments in the second quarter, we expect US revenue trends for the second half of 2025 to be roughly in line with the first half. We also expect increased competitive pressures on the ex-US MS business in the second half of 2025, particularly for TECFIDERA in Europe. And as I mentioned previously, we expect minimal contract manufacturing revenue in Q4 this year due to planned plant maintenance activities.

除去第二季 7,500 萬美元的庫存優惠和一次性的毛利對淨利調整，我們預計 2025 年下半年美國的營收趨勢將與上半年大致持平。我們也預計，2025 年下半年美國以外的 MS 業務的競爭壓力將加大，尤其是歐洲的 TECFIDERA。正如我之前提到的，由於計劃中的工廠維護活動，我們預計今年第四季的合約製造收入將很少。

Importantly, we remain on track to deliver the $1 billion of gross savings and $800 million of net savings under our Fit-for-Growth initiative. In the second half of 2025, we plan to make additional investments in R&D to enable acceleration and expansion of clinical development activities, primarily in support of rare disease.

重要的是，我們仍有望在「適應成長」計畫下實現 10 億美元的總節約和 8 億美元的淨節約。2025 年下半年，我們計劃在研發方面進行額外投資，以加速和擴大臨床開發活動，主要用於支持罕見疾病。

On this call, we talked about our excitement around moving salanersen to registrational studies and plans for our fourth indication for felzartamab. As we continue to expand our increasingly exciting pipeline, we believe it's important to make these investments in support of our long-term growth objectives. We now expect combined non-GAAP R&D and SG&A expense for the full year 2025 to be approximately $4 billion.

在這次電話會議上，我們談到了將 salanersen 轉移到註冊研究的興奮之情，以及 felzartamab 的第四個適應症的計劃。隨著我們繼續擴大日益令人興奮的產品線，我們認為進行這些投資對於支持我們的長期成長目標非常重要。我們現在預計 2025 年全年非 GAAP 研發及銷售、一般及行政費用總計約 40 億美元。

Please be sure to review this slide and our press release for other important guidance assumptions. Finally, we continue to focus on capital deployment that provides long-term value for our shareholders.

請務必查看此投影片和我們的新聞稿，以了解其他重要的指導假設。最後，我們繼續專注於為股東提供長期價值的資本配置。

And with that, I will pass the call back to Tim to open the call for questions.

說完這些，我將把電話轉回給提姆，讓他開始提問。

Thanks, Rob. And Cynthia, could we go to the first question, please?

謝謝，羅布。辛西婭，我們可以開始第一個問題嗎？

(Operator Instructions) Phil Nadeau, TD Cowen.

（操作員指示）Phil Nadeau，TD Cowen。

Congrats on the strong quarter. I had questions actually on the AHEAD 3-45 trial with potential for an interim in the (inaudible) TRAILBLAZER-ALZ 3 coming up, there's a lot of focus on early Alzheimer's. Could you remind us whether there's a similar interim in AHEAD 3-45 and maybe more broadly discuss the differences in design between AHEAD 3-45 and TRAILBLAZER-ALZ 3? Thank you.

恭喜本季業績強勁。我實際上對 AHEAD 3-45 試驗有一些疑問，該試驗有可能在即將進行的 (聽不清楚) TRAILBLAZER-ALZ 3 中期進行，其中重點關注早期阿茲海默症。您能否提醒我們 AHEAD 3-45 中是否有類似的過渡，並更廣泛地討論 AHEAD 3-45 和 TRAILBLAZER-ALZ 3 之間的設計差異？謝謝。

Priya?

普里婭？

Thank you. So I think stepping back, we believe that the potential for amyloid therapies in the presymptomatic population is very significant. It's very important for patients. We would be interested in seeing what our competitor generates. But if they have a successful trial, I think that would be helpful for patients and the amyloid class. But there are very important and significant differences between how we have attempted to address the questions that face prescribers when they think about drugs for -- anti-amyloid drugs for the presymptomatic population.

謝謝。因此，我認為退一步來說，我們認為澱粉樣蛋白療法在症狀出現前的人群中的潛力非常大。這對患者來說非常重要。我們很有興趣看看我們的競爭對手創造了什麼。但如果他們的試驗成功，我認為這對患者和澱粉樣蛋白有幫助。但是，當我們試圖解決處方醫生在考慮為症狀出現前人群提供抗澱粉樣蛋白藥物時所面臨的問題時，我們遇到了非常重要和顯著的差異。

The first and most important one is the scientific questions we are asking. So in AHEAD 3-45, these are two trials: AHEAD 3, which attempts to ask the question of whether we can prevent further accumulation of amyloid; and AHEAD 45 is asking the question of whether we can actually prevent cognitive decline in patients who have greater than 40 centiloids amyloid already in the brain. The second piece here is that we were quite specific in our recruitment and inclusion of patients.

第一個也是最重要的一個是我們正在提出的科學問題。因此，在 AHEAD 3-45 中，有兩個試驗：AHEAD 3 試圖探究我們是否可以防止澱粉樣蛋白的進一步積累；AHEAD 45 則探究我們是否能夠真正防止大腦中已經有超過 40 個百分位數澱粉樣蛋白的患者的認知能力下降。第二點是我們在招募和納入患者方面非常具體。

We used the amyloid PET to screen patients before we brought them in, and we used a CDR global score 0, which is actually no cognitive decline at all, whereas our competitor has used a mixed inclusion criteria, which included telephone interviews for inclusion, but also the CDR global score of 0.5 and 1 were included, which means mild and MCI dementia were included at the baseline. So that's an important aspect.

我們在將患者納入研究之前，使用澱粉樣蛋白 PET 來篩檢患者，並且我們使用的 CDR 總體評分為 0，這實際上表示根本沒有認知能力下降，而我們的競爭對手使用了混合納入標準，其中包括電話訪談，但也包括 CDR 總體評分 0.5 和 1，這意味著在基線時包括輕度和 MCI 癡呆。這是一個重要的面向。

Finally, I think that it's the endpoints. So I think for us, for AHEAD 3, we're looking at a biomarker endpoint, which we believe will be very important. But for AHEAD 45, we're looking at a sensitive specific preclinical Alzheimer's disease composite endpoint. So I think overall, this is going to be very different trials, and we are looking for a readout in 2028. With a question of interim analysis, we reserve optionality, of course, but at the moment, we are planning for 2028. Thank you.

最後，我認為這是終點。因此我認為對我們來說，對於 AHEAD 3，我們正在研究生物標記終點，我們認為這非常重要。但對於 AHEAD 45，我們正在研究敏感的特定臨床前阿茲海默症複合終點。所以我認為總的來說，這將是非常不同的試驗，我們希望在 2028 年獲得結果。對於中期分析的問題，我們當然保留選擇權，但目前我們正在為 2028 年做規劃。謝謝。

Eric Schmidt, Cantor.

埃里克·施密特，領唱者。

And what a pleasure to follow Phil Nadeau on this call. I also have a question on LEQEMBI, maybe this one for Alisha, more on the market side. We've seen some third-party data that suggest that [McKenzie] may be losing a little bit of share in the US. So wonder if you might comment on the competitive dynamic. Obviously, (inaudible) at a recent label update for safety, which might enhance their competitive positioning.

很高興在這次通話中跟隨 Phil Nadeau。我對 LEQEMBI 也有一個問題，也許這個問題是針對 Alisha 的，更多的是關於市場方面的問題。我們看到一些第三方數據表明，[麥肯齊] 在美國可能正在失去一些市場份額。我想知道您是否可以評論一下競爭動態。顯然，（聽不清楚）最近對安全標籤進行了更新，這可能會增強他們的競爭地位。

Thank you for the question. As we anticipated and shared in the past, and I mentioned on the call, we did believe the second therapy would help expand the market by driving more physician patient caregiver awareness. And as I also mentioned, this is the first time we've seen this market grow approximately by 15% based on total new patient starts.

謝謝你的提問。正如我們過去所預期和分享的那樣，我在電話中提到，我們確實相信第二種療法將有助於擴大市場，並提高醫生對病患照護人員的認識。正如我所提到的，這是我們第一次看到這個市場以新患者總數計算成長約 15%。

And this is what we believe to be a very encouraging development. However, as far as the competitive dynamics, we are seeing that (inaudible) faces the same friction points that we did with health systems that we have been actively addressing for the past two years. And it's notable that we believe the growth from our competitor is primarily among HCPs who are already prescribing LEQEMBI or physicians who are working alongside LEQEMBI prescribers at the same site. So LEQEMBI still continues to hold the majority of the market share, which is almost 70%. I think when you look at new patient starts, physicians are going to try new medications that enter the market.

我們相信這是一個非常令人鼓舞的發展。然而，就競爭動態而言，我們看到（聽不清楚）面臨著與我們過去兩年來一直在積極解決的醫療系統相同的摩擦點。值得注意的是，我們認為競爭對手的成長主要體現在已經開立 LEQEMBI 處方的 HCP 或與 LEQEMBI 處方者在同一地點工作的醫生。因此，LEQEMBI 仍然佔據大部分市場份額，接近 70%。我認為，當你看到新病人開始治療時，醫生就會嘗試進入市場的新藥物。

But we're also encouraged that we've had very strong new writer growth year to date. And also, 70% of that new writer growth came from physicians at new sites of care. And so LEQEMBI is really driving this expansion of new writers at new sites quarter to quarter.

但我們也感到鼓舞的是，今年迄今，新作家數量成長非常強勁。此外，70% 的新作者成長來自新醫療機構的醫生。因此，LEQEMBI 確實正在推動新網站新作家數量的逐季度增長。

And looking ahead, also with our maintenance option and our potential subcu options, this is going to provide really great optionality that obviously, our competitor also doesn't have. Now when we think about the new label update, it's really too early to say how that will influence a physician's choice. But what I can share is if we base it off of market research that we've done, it does indicate that several doctors were already using this type of schedule and dosing regimen prior to the label update. And also keep in mind, HCPs still need to conduct the same amount of MRIs. And so that has also not changed.

展望未來，加上我們的維護選項和潛在的子選項，這將提供非常好的可選性，顯然我們的競爭對手也沒有。現在，當我們考慮新的標籤更新時，說這將如何影響醫生的選擇還為時過早。但我可以分享的是，如果我們根據所做的市場調查，它確實表明在標籤更新之前，一些醫生已經在使用這種時間表和給藥方案。還要記住，HCP 仍然需要進行相同數量的 MRI 檢查。所以這一點也沒有改變。

And [RH] has always been an important consideration and the [RH] numbers obviously did not change that much in the dosing regimen. So it's helpful that physicians do gain more real-world experience, especially with LEQEMBI, and we're going to keep a close eye on it as we move forward.

[RH] 一直是重要的考慮因素，而且 [RH] 數字在給藥方案中顯然沒有太大變化。因此，醫生獲得更多現實世界的經驗是有幫助的，尤其是使用 LEQEMBI 的經驗，我們將在未來密切關注它。

I can add also -- thank you, Alisha. I was just going to add that there was actually an independent presentation at AAIC by [Sabbagh] et al and presented by Dr. [Burke]. And this was an indirect treatment comparison talking about the lecanemab, ARIA events and the donanemab, ARIA events based on the modified titration. And I think the conclusion from this group was that really the modified titration seems to be confined mainly to the homozygotes and that the number of patients that were in TRAILBLAZER 6 that assessed this modified titration was much smaller. And so there really wasn't a conclusion that it was very distinctly different. So I think that's an important consideration as well.

我還可以補充——謝謝你，Alisha。我只是想補充一下，[Sabbagh] 等人在 AAIC 上確實做了一個獨立報告，由 [Burke] 博士主講。這是一項間接治療比較，探討了基於改良滴定法的 lecanemab 和 donanemab 的 ARIA 事件。我認為該小組得出的結論是，修改後的滴定方法似乎主要局限於純合子，並且在 TRAILBLAZER 6 中評估這種修改後的滴定方法的患者數量要少得多。因此，實際上並沒有得出「兩者之間存在明顯差異」的結論。所以我認為這也是一個重要的考慮因素。

Michael Yee, Jefferies.

麥可‧餘 (Michael Yee)，傑富瑞集團 (Jefferies)。

Congrats on continued group progress. We had a question on the SMA market dynamics. I appreciate your development with salanersen. There are also myostatin products that could be coming in a month or and your competitor, Roche, is also very bullish on their myostatin program to drive SMA share. Maybe just comment about how you think myostatin would change the dynamics, whether you think that is additive to SMN correctors, and how would that impact you if competitors have combination products? Thank you.

祝賀團隊不斷進步。我們對 SMA 市場動態有一個疑問。我很欣賞你與 salanersen 的合作發展。還有一些肌肉生長抑制素產品可能在一個月內上市，而您的競爭對手羅氏也非常看好他們的肌肉生長抑制素計劃，以推動 SMA 份額的增長。也許只是評論一下您認為肌肉生長抑制素會如何改變動力學，您是否認為它是 SMN 校正器的添加劑，以及如果競爭對手有組合產品，這會對您產生什麼影響？謝謝。

I'll go ahead and I'll start the answer for that one. We've been looking at the myostatin dynamic for quite some time, and we do believe that will be a good additive benefit for patients. We don't see it as a main competitor for SPINRAZA for the SMA therapies that are currently being used. So we don't think that that's going to be an issue for us.

我將繼續並開始回答這個問題。我們研究肌生長抑制素的動態已經有一段時間了，我們確實相信這會為患者帶來很好的附加益處。我們並不認為它是 SPINRAZA 在目前正在使用的 SMA 療法的主要競爭對手。因此我們認為這對我們來說不是問題。

David Amsellem, Piper Sandler.

大衛·阿姆塞勒姆、派珀·桑德勒。

Wanted to ask a question about the lupus pipeline. First on dapirolizumab, maybe give us a sense of when the earliest -- when is the earliest you can -- we can see data from that second Phase III? And just more broadly, you're taking a multi-mechanistic approach to lupus drug development. But I wanted to pick (inaudible) on the competitive landscape. We do have oral agents like (inaudible), for instance, that are in late-stage development here.

想問一個關於狼瘡管道的問題。首先是達匹羅利珠單抗，請告訴我們最早什麼時候可以看到第二階段 III 期的數據？更廣泛地說，您正在採取多機制方法來開發狼瘡藥物。但我想挑選一下（聽不清楚）競爭格局。例如，我們確實有一些口服藥物，例如（聽不清楚），目前正處於後期開發階段。

Obviously, we have to see what the data looks like. But how are you thinking about dapirolizumab and litifilimab in the context of a more crowded landscape that potentially could include oral agents? Thank you.

顯然，我們必須看看數據是什麼樣的。但是，在可能包括口服藥物的更擁擠的藥物市場背景下，您如何看待達匹羅利珠單抗和利替利單抗？謝謝。

Thank you, David. So I think overall, I think the first comment I'd like to make is the fact that the way we've tackled lupus is really looking at the unmet need. And when you look at the unmet need, I think it quickly becomes apparent that despite a very competitive investigational landscape, dapi was actually only the third agent ever to have a positive Phase III trial. And that tells you quite a bit about the heterogeneity, the variability in the patient population and the unmet need that is still outstanding.

謝謝你，大衛。所以我認為總的來說，我想說的第一點是，我們治療狼瘡的方法實際上是在關注未滿足的需求。當你看到尚未滿足的需求時，我想很快就會發現，儘管研究環境競爭非常激烈，但 dapi 實際上只是第三個在 III 期試驗中取得積極成果的藥物。這在很大程度上說明了患者群體的異質性、多變性以及尚未滿足的需求。

The second piece here is we have attempted to tackle this from like a very broad holistic perspective. And that I mean by mechanism of action. So with litifilimab we are really trying to tackle the type 1 interferon signature. We are looking at the BDCA2, and we have proof-of-concept in Phase II with our Part A and Part B, both in cutaneous and systemic lupus.

第二點是我們試圖從非常廣泛的整體視角來解決這個問題。我指的是作用機轉。因此，我們確實在嘗試利用利替利單抗來解決 1 型乾擾素特徵。我們正在研究 BDCA2，並且我們在第二階段對 A 部分和 B 部分進行了概念驗證，包括針對皮膚紅斑狼瘡和系統性紅斑狼瘡。

And with dapi, we are looking at a much broader perspective of the CD40 ligand, CD40 pathway, which affects both T and B cells. And the data that we generated from our first Phase III gives us confidence that really we are being able to target the disease in an effective manner because we showed the impact on (inaudible) but importantly, not just (inaudible), we also showed the importance of dapi on severe -- moderate to severe patient population and in decreasing flares, so decreasing 50% of the severe flares and then also steroid sparing.

透過 dapi，我們可以從更廣泛的角度看待影響 T 細胞和 B 細胞的 CD40 配體和 CD40 路徑。我們從第一階段 III 期臨床試驗中獲得的數據讓我們相信，我們確實能夠以有效的方式針對這種疾病，因為我們展示了對（聽不清楚）的影響，但重要的是，不僅僅是（聽不清楚），我們還展示了 dapi 對重度——中度至重度患者群體和減少發作的重要性，因此減少了 50% 的重度發作，然後還節省了類固醇。

And then I just presented today, of course, the fatigue data that we also presented earlier this year at EULAR. So we think that this is a very important high unmet need area, and we're tackling it from a scientific perspective by looking at different phenotypes, and we think these will be complementary.

當然，我今天剛展示了我們今年早些時候在 EULAR 上展示過的疲勞數據。因此，我們認為這是一個非常重要的未滿足需求領域，我們正在從科學的角度透過觀察不同的表型來解決這個問題，我們認為這些將是互補的。

I'll also say that we are trying felzartamab, which is an anti-CD38, and it's in Phase I, but we remain excited about the mechanism of action for lupus nephritis. We are continuing to look at different aspects. And to the question about when we might see data, I think we expected in the '27, '28 time frame for the second Phase III. But we expect litifilimab, SLE data as early as late next year.

我還要說的是，我們正在嘗試抗 CD38 藥物 felzartamab，目前處於 I 期臨床試驗階段，但我們仍然對其治療狼瘡性腎炎的作用機制感到興奮。我們正在繼續研究不同的方面。至於我們何時可以看到數據的問題，我認為我們預計第二階段的第三階段將在 27、28 年期間進行。但我們預計最快將於明年年底獲得 litifilimab 和 SLE 的數據。

Yeah. And Michael, we have, as you may have seen in the press release, planned a seminar to do a deep dive on lupus as much as we just did with felzartamab in the past quarter. I think this notion of heterogeneity is extremely important. We had a panel of four patients talk to our senior executives. And one of the things I remember very distinctive from that is one patient saying to another, your lupus is not my lupus.

是的。邁克爾，正如您可能在新聞稿中看到的那樣，我們計劃舉辦一次研討會，深入探討狼瘡問題，就像我們上個季度對 felzartamab 所做的那樣。我認為異質性的概念極為重要。我們安排了由四名患者組成的小組與我們的高階管理人員進行交談。我記得最清楚的一件事就是一個病人對另一個病人說，你的狼瘡不是我的紅斑性狼瘡。

And I think that is what's made it very difficult to develop drugs here. I think one of the things that benefits Biogen is our experience in MS. Yes, there will be oral therapies. But I think if you look at the MS market, Alisha, what was the total share of the orals in the total MS market?

我認為這就是在這裡開發藥物非常困難的原因。我認為 Biogen 的優勢之一是我們在 MS 方面的經驗。是的，會有口服療法。但我想，如果你看一下 MS 市場，Alisha，口服藥物在整個 MS 市場中所佔的總份額是多少？

It was a third.

這是第三次。

It was about a third. So I wouldn't just go and automatically say an oral is going to beat an injectable in this market. Efficacy, I think, is going to matter. But there are also different symptoms. Some have expressed fatigue, and then there's the flares, and there's the joint pain. There's the skin issues.

大約是三分之一。因此，我不會想當然地認為口服藥物在這個市場上會勝過注射藥物。我認為功效很重要。但也有不同症狀。有些人表現出疲勞，然後出現症狀，還有關節痛。存在皮膚問題。

So it's a complex disease. And as I say, I think we'll have an opportunity to a deeper dive in September, and we welcome everybody to that seminar.

所以這是一種複雜的疾病。正如我所說，我認為我們將有機會在九月進行更深入的探討，我們歡迎大家參加該研討會。

Umer Raffat, Evercore.

烏默·拉法特（Umer Raffat），Evercore。

I wanted to touch up briefly on your long-term commitment to Alzheimer's and the status of ASI relationship. I'm asking in part because it seems like there's been an arbitration initiated by Biogen on commercialization allocations in Europe and whether it's equitable or not. So I'm just curious how the ASI relationship is going and where the disagreements may be.

我想簡單談談您對阿茲海默症的長期承諾以及 ASI 關係的現狀。我之所以問這個問題，部分原因是 Biogen 似乎已經就歐洲的商業化分配及其是否公平發起了仲裁。所以我只是好奇 ASI 關係進展如何以及分歧可能在哪裡。

So I'll start with first, we are very committed to Alzheimer's and have been for years. Actually, the partnership with ASI, I think, goes back at least 10 years. And obviously, our investment in (inaudible) is extremely important to the future of the company. And we continue to actually do research and other modalities.

首先，我們非常致力於阿茲海默症的研究，並且已經堅持了很多年。實際上，我認為與 ASI 的合作至少可以追溯到 10 年前。顯然，我們對（聽不清楚）的投資對公司的未來極為重要。我們實際上仍在繼續進行研究和其他方式。

Biogen has a history of multiple partnerships and collaborations. It's not always easy for companies to work together. And it's normal because a lot of things are just never black and white in terms of how we approach them.

Biogen 擁有多位合作夥伴的歷史。公司之間合作並不總是那麼容易。這是很正常的，因為就我們處理很多事情的方式而言，它們從來都不是黑白分明的。

I would say the relationship with ASI is better than it has ever been. And when I look at the amount of executive time at Biogen that we spend actually in different committees with our colleagues at ASI, I think the relationship that Alisha and her team have with her counterparts is extremely strong. Manufacturing, our Head of Manufacturing, just recently had a one-on-one meeting with the CEO of ASI in Japan, and that was since the arbitration was filed. We have this on the development side. I think there's a very close working relationship.

我想說與 ASI 的關係比以往任何時候都好。當我看到我們在 Biogen 與 ASI 的同事在不同的委員會中實際花費的執行時間時，我認為 Alisha 和她的團隊與她的同事之間的關係非常牢固。製造部門，我們的製造主管，最近剛與日本 ASI 的執行長進行了一對一會談，這是自仲裁提起以來。我們在開發方面有這個。我認為我們之間存在著非常密切的工作關係。

But there are times where there is going to be a disagreement. And I think we have that in terms of how we launch in Europe. And we're just following the process in our contract. And so I think that will go to arbitration. I don't think there's anything particular about it. It happens in relationships, but it hasn't affected the overall working relationship with ASI.

但有時還是會發生分歧。我認為，就我們在歐洲的推出方式而言，我們已經做到了這一點。我們只是按照合約中的流程行事。所以我認為這將進入仲裁程序。我認為這沒什麼特別之處。這在人際關係中會發生，但並沒有影響與 ASI 的整體工作關係。

Brian Abrahams, RBC Capital Markets.

加拿大皇家銀行資本市場 (RBC Capital Markets) 的 Brian Abrahams。

Congrats on the quarter. It seems like the use of the blood-based biomarkers is expanding pretty considerably. I was wondering if you could talk a little bit more about how you educate further around proper patient triage leveraging these new diagnostics and what your sense is just from being in the field on what it's going to take to convince neurologists that these can be used in place of PET or CSF. Is this something that could potentially happen soon? And what sort of inflection might we see in being amyloid option after that? Thanks.

恭喜本季取得佳績。看起來血液生物標記的用途正在大大擴展。我想知道您是否可以進一步談談如何利用這些新診斷技術對患者進行正確的分類，以及您從該領域的經驗來看，如何才能讓神經科醫生相信這些技術可以取代 PET 或 CSF。這是可能很快發生的事情嗎？那麼，此後我們可能會看到澱粉樣蛋白選項發生什麼樣的變化呢？謝謝。

Yeah. Alisha, I think you can say that you're seeing an awful lot of activity on this in the market. Can you perhaps give a little more color commentary there?

是的。Alisha，我想您可以說，您看到市場上有大量此類活動。您能否給予更多一些詳細的評論？

Yeah. Thank you for the question. the Alzheimer's blood tests are evolving at an incredible pace right now. In fact, it's way more than what we thought it was going to be at this time point. And so we do believe this is a pivotal moment, especially when it comes to diagnosing patients.

是的。感謝您的提問。阿茲海默症血液檢查目前正以驚人的速度發展。事實上，它遠遠超出了我們當時所認為的水平。因此，我們確實相信這是一個關鍵時刻，尤其是在診斷患者方面。

As I mentioned in my opening remarks, testing nearly tripled in the past year. And just this week, the Alzheimer's Association issued their first practice guidelines for blood-based biomarkers. So these tests, as you're probably well aware, are more convenient, faster, and cheaper compared to what's out there now at CSF or PET. So the market dynamics are fluid, but I can share with you what we understand as of today, which I'm sure is going to even change when we get to the next earnings call.

正如我在開場白中提到的，去年的測試數量幾乎增加了兩倍。就在本週，阿茲海默症協會發布了第一份基於血液的生物標記的實踐指南。因此，正如您可能知道的，這些測試與現有的 CSF 或 PET 測試相比更方便、更快捷、更便宜。因此，市場動態是不斷變化的，但我可以與大家分享我們今天的了解，我相信在下一次財報電話會議上，這些了解還會改變。

So first and foremost, our market research shows that neurologists have an extremely high awareness, and many are already using these tests. Now if you're already prescribing an anti-amyloid therapy, you also have a higher propensity for writing these tests as well and performing them on patients. But according to claims data, PCPs are also adopting them. However, we believe these early adopters are only using them for a fraction of their patients. So they're not being used all the time in the offices, but they are being used for a fraction.

因此，首先，我們的市場研究表明，神經科醫生的認知度非常高，而且許多人已經在使用這些測試。現在，如果您已經開出了抗澱粉樣蛋白療法，那麼您也更有可能編寫這些測試並對患者進行測試。但根據索賠數據，PCP 也在採用它們。然而，我們相信這些早期採用者只將其用於一小部分患者。因此，它們並不是在辦公室裡一直被使用，但只被使用一小部分。

So while the utilization is growing significantly, physicians are primarily using them for triage. So this means the physician, if the test is negative, will rule out Alzheimer's. However, even when the test is positive or even in determinant, we believe most physicians are still confirming with CSF and PET scans today. The majority opportunity and the major opportunity ahead of us is to establish these tests as the standard for amyloid confirmation. In order to make the shift, we are actively positioning ourselves to drive the awareness, the education, and we need real-world evidence for physicians.

因此，雖然利用率正在大幅增長，但醫生主要將其用於分類。所以這意味著，如果檢測結果為陰性，醫生就會排除阿茲海默症。然而，即使測試結果呈陽性或不確定，我們相信大多數醫生今天仍會使用 CSF 和 PET 掃描進行確認。我們面臨的最大機會和主要機會是將這些測試確立為澱粉樣蛋白確認的標準。為了實現這一轉變，我們正在積極定位自己，以提高意識和教育，我們需要為醫生提供現實世界的證據。

So specifically, we believe education is needed about the new guidelines. Those just came out, and so we are definitely going to need to be able to disseminate that. And there are multiple tests that hit the 90% sensitivity and specificity threshold that are in the guidelines. So we also believe physicians need clarity whether these tests are sufficient for therapy reimbursement. And when I say therapy reimbursement, that will be specifically around CFS. And that is since PET -- or sorry, with CMS. And that is because only PET and CSF are mainly used today. So physicians won't know until they try to put that into their CMS database. But because not many are doing it right now instead of CSF or PET, we don't know whether they're going to get reimbursement.

因此，具體來說，我們認為需要對新指南進行教育。這些剛剛發布，所以我們肯定需要能夠傳播它們。有多個測試達到了指南中規定的 90% 敏感性和特異性閾值。因此，我們也認為醫生需要明確這些測試是否足以獲得治療報銷。當我說治療報銷時，那將專門針對 CFS。這是自從 PET 以來——或者抱歉，自從 CMS 以來。這是因為目前主要只使用 PET 和 CSF。因此，醫生只有嘗試將其放入 CMS 資料庫時才會知道。但由於目前很少人選擇這項檢查來代替 CSF 或 PET 檢查，我們不知道他們是否會獲得報銷。

So we are going to work through clarity with the payers and with the physicians to make sure that they have that. So it is rapidly evolving, but there is significant potential to accelerate the diagnosis for patients. And so we are very much encouraged by what we're seeing in the market today. And we do see that the amount of tests are really accelerating even our predictions until year-end.

因此，我們將與付款人和醫生一起努力，確保他們能夠做到這一點。因此它正在快速發展，但在加速患者診斷方面具有巨大的潛力。因此，我們對當今市場的表現感到非常鼓舞。我們確實看到，到年底，測試的數量確實在加速成長，甚至超過了我們的預測。

Jay Olson, Oppenheimer.

傑伊·奧爾森，奧本海默。

Congrats on the quarter, and thanks for the update. First question is about subcu LEQEMBI. You had important data updates on LEQEMBI at AAIC. And as Alisha indicated earlier, subcu seems like a key differentiator from donanemab. So can you talk about any feedback you got from physicians at AAIC? How large is the incremental patient population you can address with subcu? And is there an opportunity for a direct-to-consumer education about subcu LEQEMBI? Thank you.

恭喜本季取得佳績，感謝您的更新。第一個問題是關於subcu LEQEMBI。您在 AAIC 上獲得了有關 LEQEMBI 的重要數據更新。正如 Alisha 之前指出的，subcu 似乎是與 donanemab 的關鍵區別。那麼您能談談您從 AAIC 的醫生那裡得到的任何回饋嗎？透過皮下注射可以治療的新增患者數量有多少？是否有機會直接針對消費者進行 subcu LEQEMBI 的教育？謝謝。

Do you want to start with LEQEMBI, Priya and then Alisha?

您想先從 LEQEMBI 開始，然後是 Priya，最後是 Alisha 嗎？

Yeah, I can start. So overall, we're really excited because as we had mentioned at the outset of 2025, we believe that blood-based biomarkers was going to be an important catalyst. I think you just heard from Alisha that this is ongoing. And the second one really was the intravenous maintenance that we got approval for for LEQEMBI. And now we are on to a week away from our PDUFA date for subcutaneous maintenance. So we think that this is -- if we get approval, this would be a really important movement in the field because it adds convenience and optionality, remove some of the barriers to treat and streamline the infrastructure.

是的，我可以開始了。所以總的來說，我們真的很興奮，因為正如我們在 2025 年初提到的那樣，我們相信基於血液的生物標記將成為重要的催化劑。我想您剛剛從 Alisha 那裡聽說這件事正在進行中。第二個實際上是我們獲得 LEQEMBI 批准的靜脈維持治療。現在距離皮下維持治療的 PDUFA 日期還有一週。因此我們認為，如果我們獲得批准，這將是該領域一個非常重要的舉措，因為它增加了便利性和可選性，消除了一些治療障礙並簡化了基礎設施。

The goal with subcutaneous auto-injector maintenance is really to give patients the option to transition weekly at home injections after completing the intravenous LEQEMBI initiation period. And we are also getting ready to file for subcutaneous initiation LEQEMBI therapy, and we shared data on bioequivalents just yesterday at AAIC.

皮下自動注射器維護的目標實際上是讓患者在完成靜脈 LEQEMBI 啟動期後可以選擇每週在家注射。我們也準備好申請皮下啟動 LEQEMBI 療法，昨天我們在 AAIC 分享了生物等效性數據。

So overall, we are really excited about the opportunity. And yes, it's a differentiator. It also has a safety advantage because we don't see it's a very big difference and very much smaller number of infusion reactions that we see with subcutaneous versus intravenous. So we think it's quite an advantage with safety and efficacy really looking very equivalent.

總的來說，我們對這個機會感到非常興奮。是的，這是一個差異化因素。它還具有安全優勢，因為我們沒有發現皮下注射和靜脈注射之間存在很大差異，而且輸液反應的數量也少得多。因此我們認為這是一個相當大的優勢，因為安全性和有效性確實看起來非常相當。

With that, I'm going to turn it over to Alisha. And before I do, overall, we have conducted a lot of ad boards and talked to a lot of our key opinion leaders, and there's a lot of enthusiasm for subcutaneous. But I'm going to turn to Alisha for more details on that.

說完這些，我要把它交給 Alisha。在我這樣做之前，總的來說，我們已經進行了很多廣告看板宣傳，並與許多關鍵意見領袖進行了交談，人們對皮下注射表現出了極大的熱情。但我將向 Alisha 詢問有關此問題的更多詳細資訊。

Thank you, Priya. As with any market, physicians and patients love options, and they love flexibility. So any time we come out with anything that offers those two things, the market gets excited over them. With that being said, and I know the question is about subcu, but even IV maintenance has been really welcomed by the community.

謝謝你，普里婭。與任何市場一樣，醫生和患者喜歡選擇，也喜歡靈活性。因此，每當我們推出能夠提供這兩點的產品時，市場都會感到興奮。話雖如此，我知道問題是關於皮下注射的，但即使是靜脈注射維護也受到了社區的歡迎。

And even though patients are just hitting their 18-month marks, we are getting feedback that patients are rolling off, they are moving on to the IV maintenance. And honestly, it gives them, again, more optionality and flexibility, not having to come in twice a month. And so that's already been a positive.

儘管患者剛達到 18 個月的治療期限，但我們收到的回饋是，患者正在逐漸康復，並開始接受靜脈注射維持治療。老實說，這再次為他們提供了更多的選擇和靈活性，而不必每月來兩次。所以這已經是積極的了。

Now we introduce subcu. Physicians have said in market research and also in conversations that we've had then they will, if we do have the potential approval of this happening for either initiation or for maintenance, they will offer all the options to the patients, and they will allow the patient to decide what is best for them.

現在我們來介紹一下subcu。醫生在市場調查和我們的談話中都表示，如果我們確實有可能批准這種療法用於啟動或維持治療，他們會向患者提供所有的選擇，讓患者自己決定什麼對他們來說是最好的。

We do have many patients that live in rural areas, and we are hearing that those in rural areas will probably want to go on subcu, and they will choose to go on subcu. And yet we also have patients who are on IV who enjoy coming into the infusion centers. And so it really will be a patient choice and what's going to be good for their lifestyle. But I will say that physicians love that they are going to have so many different options when it comes to the LEQEMBI.

我們確實有很多生活在農村地區的患者，我們聽說農村地區的患者可能想要接受皮下注射治療，而且他們會選擇接受皮下注射治療。然而，我們也有接受靜脈注射的患者喜歡來到輸液中心。所以這確實是一個患者的選擇，並且有利於他們的生活方式。但我要說的是，醫生們很高興看到 LEQEMBI 有如此多的不同選擇。

Salveen Richter, Goldman Sachs.

薩爾文·里克特，高盛。

Just following up on the business development commentary earlier. How important of a lever is this for you now as you do have a cadence of pipeline drivers that you're as you look to year-end and beyond? And so in that context, are you looking for earlier stage assets? And is I&I the main focus, given the interest in building out that vertical? Thank you.

只是跟進之前的業務發展評論。當您展望年底及以後時，您確實擁有一系列管道驅動程序，這對您來說有多重要？那麼在這種背景下，您是否正在尋找早期資產？考慮到對建構垂直領域的興趣，I&I 是否是主要關注點？謝謝。

Yeah. Thanks, Salveen. I mean definitely early stage is on the cards because I do think we actually have a very strong late-stage pipeline. And I think one of the things I have seen in my long career is we don't -- we haven't spent enough time, particularly at senior management levels, on research. And that's really where you can bring in assets on a very cost-effective basis. And you can use some of the strength of the larger company to really shape those molecules into medicines.

是的。謝謝，薩爾文。我的意思是，早期階段肯定是有可能的，因為我確實認為我們實際上擁有非常強大的後期研發管線。我認為在我漫長的職業生涯中看到的事情之一是我們沒有——我們沒有花足夠的時間在研究上，特別是在高階管理層。這確實可以讓你以非常經濟的方式引入資產。你可以利用一些大公司的力量將這些分子真正塑造成藥物。

And we've done a complete revamp of our research organization and significantly reduced the head count, but not with the idea of investing less, but investing differently. And so we will be doing a lot more of the City Therapeutics type deals. And I think even actually as we look at HI-Bio, we've been able to retain the entire organization. And they found a way culturally within Biogen so that the large company capabilities such as procurement, being able to do clinical trials worldwide can assist actually the entrepreneurial and agile team of HI-Bio, for example. And that's what we'd like to do on the early stage and really make sure that we're not in this same period of having a pipeline gap 10 years from now.

我們對研究機構進行了徹底改組，大幅減少了員工人數，但這並不是減少投資，而是以不同的方式進行投資。因此，我們將會進行更多類似 City Therapeutics 類型的交易。我認為，即使我們實際上審視 HI-Bio，我們也能夠保留整個組織。他們在 Biogen 內部找到了一種文化方式，以便大型公司的能力（例如採購、能夠在全球範圍內進行臨床試驗）可以真正協助 HI-Bio 的創業和敏捷團隊。這就是我們在早期階段想要做的事情，並確保我們不會再在 10 年後面臨同樣的管道缺口。

Now that said, we are still also looking at other assets. Your interest in doing late-stage M&A is inversely proportional to your confidence in the pipeline. And that's not just because of the confidence, but you're also concerned about distraction. I think we're pioneering in a number of new areas. We're building up a huge team on lupus and looking at nephrology, really prelaunching these programs.

話雖如此，我們仍在關注其他資產。您對進行後期併購的興趣與您對通路的信心成反比。這不僅是因為信心，還因為擔心分心。我認為我們在許多新領域都處於領先地位。我們正在組建一個龐大的狼瘡研究團隊並研究腎臟病學，真正地預先啟動這些計畫。

So as we look at opportunities, and I always say you can never have enough pipeline, it has to fit strategically with what we're already doing. We don't want to stretch our teams more than we need to. And it has to make financial sense. And there are some assets out there not everybody thinks that they're appropriately valued, and that makes it difficult sometimes to get deals done. And there are some things that are overvalued.

因此，當我們尋找機會時，我總是說你永遠不會有足夠的管道，它必須在策略上與我們已在做的事情相適應。我們不想讓我們的團隊承受超過必要的壓力。而且它必須具有財務意義。有些資產並不是所有人都認為其估值合理，有時會使交易難以完成。有些東西被高估了。

But we're looking, but I think we're increasingly confident in the future of Biogen. I think we've got the company really firing on all cylinders. It's performing well. So if we find something that really we believe will add shareholder value, we'll do it. But otherwise, I think we're really focused on the whole spectrum as a development chain.

但我們正在關注，但我認為我們對 Biogen 的未來越來越有信心。我認為我們已經讓公司真正全面開動了。它表現良好。因此，如果我們發現某些事情確實能夠增加股東價值，我們就會去做。但除此之外，我認為我們真正關注的是整個開發鏈。

Paul Matteis, Stifel.

保羅·馬泰斯（Paul Matteis），Stifel。

This is Julian on for Paul. I guess just specifically, again, following up on subcutaneous lecanemab. I think people are really trying to better understand the logistics of (inaudible) subcutaneous initiation would actually work when that eventually comes online. And do you foresee this primarily being administered initially in centers and then patients are slowly sort of rolled out to having this drug administered at home? Or I'm just curious on how you see this playing out and what sort of value this will ultimately bring, just given the concerns over ARIA for this class of agents. Thank you.

這是朱利安 (Julian) 代替保羅 (Paul)。我想只是具體地再次跟進皮下注射 lecanemab。我認為人們確實在試圖更好地理解（聽不清楚）皮下啟動的後勤工作，當它最終上線時，它實際上會起作用。您是否預見到這種藥物最初主要在中心進行管理，然後慢慢地讓患者在家中服用這種藥物？或者我只是好奇，考慮到 ARIA 對這類代理商的擔憂，您如何看待這種情況以及最終會帶來什麼樣的價值。謝謝。

I can start, Julian. So this is Priya. So overall, the way we've conducted the trials and the way we've generated the data, we actually have optionality that this is a self-administration that can be done by the patient, the caregiver, medical staff, or the physicians. So we retain that optionality. Exactly how we are envisaging and projecting that it will be used, I'm actually going to turn it over to Alisha.

我可以開始了，朱利安。這就是 Priya。因此，總的來說，我們進行試驗的方式和產生數據的方式實際上具有選擇權，即患者、護理人員、醫務人員或醫生可以自行管理。因此我們保留了這種可選性。至於我們設想和預測它將如何被使用，我實際上將把它交給 Alisha。

And before I do, we did talk about at AAIC, we presented data from our human factor study was very encouraging. I encourage you all to look at that because it shows that, actually, patients with training were able to do this on their own. And the auto-injector is fairly simple to use. So it was very encouraging and exciting data, but I'm going to turn it to Alisha to talk more about the actual logistics.

在此之前，我們確實在 AAIC 上討論過，我們展示的人為因素研究數據非常令人鼓舞。我鼓勵大家看看這一點，因為它表明，實際上，經過訓練的患者能夠自己做到這一點。自動注射器的使用相當簡單。所以這是非常令人鼓舞和令人興奮的數據，但我將讓 Alisha 來更多地談論實際的物流。

Thank you, Priya. With the initiation of subcu, we believe that that's going to be an excellent opportunity, not only for patients but also the physicians and especially these high-writing physicians which we now have many of them, gives them an opportunity not to take up a chair for a patient who might need them, especially if they decide to go on to IV.

謝謝你，普里婭。隨著皮下注射的開展，我們相信這將是一個絕佳的機會，不僅對患者如此，對醫生也如此，特別是對我們現在擁有的許多高水平寫手醫生而言，這讓他們有機會不必為可能需要他們的患者佔座位，特別是如果他們決定繼續進行靜脈注射的話。

So with the subcu, when we speak to physicians or we look at market research, what it shows is it will depend on the patient situation, whether they have a caregiver or not and whether that physician feels that they are very good at obviously managing ARIA. You have some physicians now who are earlier in their writing stages of LEQEMBI, and they still like to have the hands on and want to see the patient and have them come in. You have others who have hundreds of patients, and they feel totally fine with starting a patient on subcu.

因此，對於 subcu，當我們與醫生交談或進行市場調查時，結果顯示這將取決於患者的情況，他們是否有護理人員，以及醫生是否認為他們非常擅長管理 ARIA。現在有些醫生正處於 LEQEMBI 的早期編寫階段，他們仍然喜歡親自動手，希望看到病人並讓他們進來。其他人有數百名患者，他們完全同意為患者開始皮下注射。

And so I do believe that it will come down to that conversation in the patient that's sitting in front of them, whether the patient wants to inject themselves, do they have a caregiver. We're also looking at is there a possibility of giving them support at home with injections, so they don't have to come into the office. And also, we do have the optionality of them coming into the office.

因此，我確實相信，這將取決於坐在他們面前的病人之間的對話，無論病人是否想自己注射，是否有護理人員。我們也在研究是否有可能透過注射為他們提供在家的支持，這樣他們就不必來辦公室了。而且，我們確實可以選擇讓他們來辦公室。

So again, this will be something where they really will have a lot of flexibility on that decision-making, and it will be tailored towards what that patient needs at that point in time.

所以，再次強調，這將意味著他們在決策上將擁有很大的靈活性，並且將根據患者當時的需求量身定制。

Myles Minter, William Blair.

邁爾斯·明特、威廉·布萊爾。

This is Jake on for Myles. Question about felzartamab and AMR. Just wondering how you guys are modeling that potential market and how the results from the [DARDAR] study with DARZALEX have sort of influenced your expectations about potential expansion into the pe-transplantation setting? Thanks.

這是傑克 (Jake) 取代邁爾斯 (Myles)。關於 felzartamab 和 AMR 的問題。只是想知道你們是如何模擬這個潛在市場的，以及 DARZALEX 的 [DARDAR] 研究結果如何影響你們對潛在擴展到人體移植領域的預期？謝謝。

Yeah. I think on the addressable market, as we noted on the thematic seminar, there's about 11,000 patients per year. If you take the average IgAN price, just as one idea of where value could be, that's about $150,000. So if you look at the addressable market, it's probably in the order of something around $1.5 billion. So it's a significant opportunity in itself.

是的。我認為在目標市場上，正如我們在專題研討會上指出的那樣，每年大約有 11,000 名患者。如果採用 IgAN 的平均價格，那麼作為價值的概念，其價值約為 150,000 美元。因此，如果你看一下目標市場，它的規模可能在 15 億美元左右。所以這本身就是一個重大機會。

We do think that basically felzartamab will be the best positioned. We're doing all of the studies for this. This is precision immunology here. So we still think we're going to be first to market here, and we will be able to make the most use of that -- take most advantage of that market.

我們確實認為 felzartamab 基本上處於最佳定位。我們正在為此進行所有研究。這就是精準免疫學。因此，我們仍然認為我們將首先進入這個市場，並且我們將能夠充分利用這一點——充分利用這個市場。

I'll just add one point. Thanks, Chris. I'll just add that we announced today that we are also going to be investigating felzartamab opportunity in late MVI.

我只想補充一點。謝謝，克里斯。我還要補充一點，我們今天宣布，我們還將在 MVI 後期調查 felzartamab 的機會。

And this is important because the late MVI is actually a newly classified kidney transplant rejection phenotype. And it's just been added to the ramp classification because it was previously classified, these patients were classified as no AMR because they had a lack of donor-specific antibodies, which has a very high risk of graft failure. And now here, we're thinking about the felzartamab mechanism of action targeting the CD38 positive natural killer cells, which we believe are very important for disease and pathology. And so there's a scientific rationale.

這很重要，因為晚期 MVI 實際上是一種新分類的腎臟移植排斥表型。它只是被添加到斜坡分類中，因為它之前被分類為無 AMR，因為他們缺乏供體特異性抗體，這具有非常高的移植失敗風險。現在，我們正在考慮針對 CD38 陽性自然殺手細胞的 felzartamab 作用機制，我們認為這對疾病和病理非常重要。這是有科學根據的。

This itself is also about 5,000 to 6,000 patients. So we think it will augment the potential opportunity in AMR.

這本身也有大約5,000到6,000名患者。因此我們認為它將增加AMR領域的潛在機會。

Thanks, Priya. Well, that's all the time we have for today. Thanks for your participation. If you've got questions and want to follow up, just to reach out to the IR team. Thank you.

謝謝，普里婭。好的，今天的時間就到這裡了。感謝您的參與。如果您有任何疑問並想跟進，請聯絡 IR 團隊。謝謝。

This concludes today's call. Thank you for your participation. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。